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Analytical Chemistry Services

Employing state-of-the-art instrumentation in HPLC, GC, GC/MS and LC/MS/MS, Synomics Pharma can develop analytical chemistry methods from first principles to validation and can verify or improve existing methods for the analysis of a wide range of active compounds. Customized analytical chemistry testing and structure elucidation are also offered. All services can be provided to meet either GLP or cGMP guidelines (or non-GLP as requested):

Analytical Chemistry Services

  • Method development
  • Method validation
  • Method verification/transfer
  • Sample analysis
  • Lot and batch release testing
  • Structure elucidation
  • Detection and identification of impurities
  • Residual solvent analysis
  • Dissolution testing
  • Product composition
  • Content – uniformity/impurities
  • Customized LC/MS/MS method development
  • Raw material testing
  • Placebo and excipient testing
  • Physical-chemical properties
  • Customized analytical testing

Expertise

Proteins and Peptides

  • Client specific compounds(Oncology, Neurological, and Antibody conjugates)

Glycosylated Peptides/proteins (HPLC Corona Aerosol Detector & LC/MS/MS) and
Small Molecules

  • Oncology
  • Hormones/prostaglandins
  • Cyclodextrins
  • Vitamin D derivatives
  • Anti-inflammatory

Stages of Development

  • Discovery (Non-GLP)
  • Pre-clinical (GLP)
  • Clinical (GLP/GMP)
  • Commercial (cGMP)

 

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